At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 215 enrolled
Drug / intervention
Vedolizumab IV +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Vedolizumab IV and Placebo for Crohn's Disease. Completed, enrolled 215 participants across 29 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2017
Primary CompletionAug 2020
TodayJul 2026
First PostedJul 31, 2017
Enrollment StartAug 3, 2017
Primary CompletionAug 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.9 years ago
Interventions
Vedolizumab IVdrug
Vedolizumab IV infusion
Placebodrug
Vedolizumab placebo-matching